History  |  Our Team

QUALITY CONTROL

In 1996, Laboratorios Clausen S.A. and the National University signed an agreement by which the Immunobiology Laboratory (LIB) of the School of Medicine carries out quality controls of Laboratorios Clausen’s biotechnological products. As part of these controls, LIB measures the biological activity and the purity of the biotechnological products, comparing them to the international standards.

These studies are performed by personnel formed in the National University and specialized in first level international institutions.
This agreement is pioneer in narrowing the relationship among the School of Medicine and the private sector of our country.

Recently, at the end of 2003, a new agreement, this time with the Science School, promoted the creation of the UCCB (Quality Control Unit of Biotechnological products).

The UCCB works as a complete unit associated between the academic sector (National University) and the private sector (Laboratorios Clausen S.A.) with the aim of guarantee quality controls in biotechnology products according to the international requirements.

DEVELOPMENT OF A NEW MOLECULE

The exchange precedents between Laboratorios Clausen and the National University made possible to face an entirely national investigation project. The first stage of this project was the development of “Design and Construction of an expression system of Human Recombinant Thrombopoietin in mammalian cells, with demonstrated biological activity”.

This project was performed by a School of Medicine investigator team, using specialized in different areas and using cellular culture methods, molecular biology and DNA recombinant techniques. This project was wholly financed by Laboratorios Clausen S.A. with a loan adjudicated by the CONICYT – FINTEC – BID project.

At the beginning of year 2000, a cellular culture which is the producer of the Human Recombinant Thrombopoietin with demonstrated biological activity, was obtained. After being evaluated by international experts in this matter, this result was declared as successful by CONICYT.

The product of this investigation was submitted in the National Patents Office. After a very exhaustive analysis, the Patent was conceded with the number 26.317.

The main objective reached by Laboratorios Clausen and the investigators team was the obtaining of rHu-TPO, the first recombinant molecule with potential pharmaceutical application in human beings, patented and developed entirely in Uruguay. At the same time, the product was submitted for the Patent study by the PCT (Patent Corporation Treaty) through Sweden in 2001 (N° IB01/01518).

Recently, the patent application has been introduced in the main countries: USA, Europe and Japan.

These goals conducted Laboratorios Clausen to the creation of the Research & Development Department, with the aim of continuing the development of new techniques and products in the medical - pharmaceutical area.

LABORATORIOS CLAUSEN - AVENTIS PASTEUR:

1. Epidemiological study of Influenza virus in Uruguay between 1995 and 2000. GROG (Flu Observation Regional Group).

2. Study of Immunogenicity and Security of Influenza vaccine in adults.

3. Study of Immunogenicity and Security of Influenza vaccine in children from 6 months to 3 years old.

4. Seroprevalence of viral Hepatitis A Infection in children aged 2 to 14 years old in Montevideo, Uruguay.

5. Epidemiologic Seroprevalence study of viral Hepatitis A infection in working population between 18 and 49 years old in Montevideo, Uruguay.

6. Vaccination against pneumococal before the hospital discharge certificate. Project presented to Internal Medicine Authorities in Uruguay in their 7th Anniversary.

7. Evaluation of the bioequivalence of a new mychophelonate mofetil pharmaceutical formulation: randomized, crossed study with unique oral administration in 12 healthy volunteers.

8. Influenza virus sentinels study, GROG 1994-2003. Poster presented at the International Congress of Infectious Diseases (ICID), Cancun, Mexico 2004. More Information.

9. Cost-benefit analysis of universal vaccination against Hepatitis A in Uruguay. Poster presented at the International Congress of Infectious Diseases (ICID) Cancun, Mexico 2004. More information.

10. Vaccines update. Vaccines and its recommendations.